1. Implementing a new drug or technique (APA Cambridge 21. June 2013) Tom G. Hansen, MD, PhD, Department of Anaesthesia & Intensive Care Odense University Hospital & University of Southern Denmark DENMARK Email: tomghansen@dadlnet.dktomghansen@dadlnet.dk

2. Tenets of evidence based- medicine

3. Hierarchy of evidence 1.Systematic review of RCTs 2.A single RCT 3.Observational studies 4.Case series and reports

4. Two caveats…….. Applicability of RCTs Quality of evidence: large observational study vs. a small RCT

5. Gap between need from public health perspective and what can be afforded

6. Slow implementation

7. Clinical guidelines The WHO definition: ……systematically developed evidence based statements which asisst providers, recipients and other stakeholders to make informed decisions about appropriate health interventions…………

8. Clinical guidelines: - Aims Appropriate care Best available evidence Multidisciplinary groups Systematic and transparent concensus processes End-user involvement Adaptations should be re-edited Guidance of doctors Do not replace knowledge and skills

9. AGREE-II (www.agreetrust.org) 23-point checklist: ….scope and purpose ….stakeholder involvement ….rigour of development ….clarity ….presentation ….applicability ….editorial independence

10. Guidelines - pros Facilitate EBM Variation in practice  Discourage outdated practice Efficiency healthcare↑  Freeing resources? Awareness on subjects↑ Source of practical advice Standardize clinical management

11. Guidelines - con Designed for ”average” patients Implementation difficult: - lack of expertise - disagreement - resources Professional judgement  Conflicts of interest Expensive Authority Duplication Lack of relevant research of high quality Legal consequences

12. Types of knowledge →Explicit knowledge →”tacit knowledge”

13. Requirements to guidelines Support not constraint Address practical questions Short and concise Standardized (e.g. AGREE-II) New→ Why? Add? Divergence? Evidense ↔ Expert opinion Conflicts of interest Reviewing Revision

14. Who develops the guidelines? Local departments/hospitals Cluster of hospitals National International/continental

15. A simple clinical question!

16. Expensive new evidence

17. The Fujii story

18. Retracted articles by Fujii 1991- 2011

19. New metaanalysis withut Fujii’s studies

20. Carlisle’s Conclusions ……………. if data with unusual distributions are removed from meta-analysis and articles by Fujii et al. excluded, then the antiemetic effects of granisetron and ramosetron are greatly reduced; further, there is no evidence of synergism between antiemetics and indeed, some evidence of antagonism between antiemetic agents…………...

21. Conclusions Transfer of research possible but success varies Gap between recommended and received healthcare Causes of knowing-doing gaps unknown Complex and context dependent process Need for assessment of interventions Best implementation strategy unknown Economics?

22. Aesop After all is said and done.…….. more is said than done…..